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The Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.

The Xia® Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The Xia® Growth Rod Conversion Set components are manufactured from titanium alloy and are designed to interact with constructs consisting of hooks, screws, connectors, and 4.5mm diameter rods. The Xia® Growth Rod Conversion Set is intended for use only with Xia® 4.5 Spinal System fusion constructs cleared for pediatric use.

The provided text describes the Xia® Growth Rod Conversion Set, a medical device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity for an AI-powered device).

This document is a 510(k) premarket notification for a medical device (Xia® Growth Rod Conversion Set), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the "Summary of the Performance Data" section (Page 4, Table "510(k) Summary") states:
"Engineering analysis demonstrated that introduction of the Growth Rod Conversion Set does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided."

This indicates that the "study" conducted was an engineering analysis to ensure the new component does not negatively impact the performance of an existing, cleared system, rather than a clinical study evaluating diagnostic accuracy or a specific set of performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is about a different type of medical device review process (510(k) for a physical implantable device) that relies on substantial equivalence and engineering analysis, not diagnostic performance metrics or human reader studies.

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